PMID- 34513681
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220426
IS  - 2234-943X (Print)
IS  - 2234-943X (Electronic)
IS  - 2234-943X (Linking)
VI  - 11
DP  - 2021
TI  - Use of a Biodegradable, Contrast-Filled Rectal Spacer Balloon in 
      Intensity-Modulated Radiotherapy for Intermediate-Risk Prostate Cancer Patients: 
      Dosimetric Gains in the BioPro-RCMI-1505 Study.
PG  - 701998
LID - 10.3389/fonc.2021.701998 [doi]
LID - 701998
AB  - BACKGROUND/PURPOSE: Dose-escalated external beam radiotherapy (RT) is effective 
      in the control of prostate cancer but is associated with a greater incidence of 
      rectal adverse events. We assessed the dosimetric gain and safety profile 
      associated with implantation of a new biodegradable rectal spacer balloon. 
      MATERIALS/METHODS: Patients scheduled for image-guided, intensity-modulated RT 
      for intermediate-risk prostate cancer were prospectively included in the French 
      multicenter BioPro-RCMI-1505 study (NCT02478112). We evaluated the dosimetric 
      gain, implantation feasibility, adverse events (AEs), and 
      prostate-cancer-specific quality of life associated with use of the balloon 
      spacer. RESULTS: After a scheduled review of the initial recruitment target of 50 
      patients by the study's independent data monitoring committee (IDMC), a total of 
      24 patients (including 22 with dosimetry data) were included by a single center 
      between November 2016 and May 2018. The interventional radiologist who implanted 
      the balloons considered that 86% of the procedures were easy. 20 of the 24 
      patients (83.3%) received IMRT and 4 (16.7%) received volumetric modulated arc 
      therapy (78-80 Gy delivered in 39 fractions). The dosimetric gains associated 
      with spacer implantation were highly significant (p<0.001) for most variables. 
      For the rectum, the median (range) relative gain ranged from 15.4% (-9.2-47.5) 
      for D20cc to 91.4% (36.8-100.0) for V70 Gy (%). 15 patients (62%) experienced an 
      acute grade 1 AE, 8 (33%) experienced a late grade 1 AE, 1 (4.2%) experienced an 
      acute grade 2 AE, and 3 experienced a late grade 2 AE. No grade 3 AEs were 
      reported. Quality of life was good at baseline (except for sexual activity) and 
      did not markedly worsen during RT and up to 24 months afterwards. CONCLUSION: The 
      use of a biodegradable rectal spacer balloon is safe, effective and associated 
      with dosimetric gains in modern RT for intermediate-risk prostate cancer.
CI  - Copyright (c) 2021 Latorzeff, Bruguiere, Bogart, Le Deley, Lartigau, Marre and 
      Pasquier.
FAU - Latorzeff, Igor
AU  - Latorzeff I
AD  - Department of Radiotherapy, Clinique Pasteur, Toulouse, France.
FAU - Bruguiere, Eric
AU  - Bruguiere E
AD  - Department of Imaging, Clinique Pasteur, Toulouse, France.
FAU - Bogart, Emilie
AU  - Bogart E
AD  - Methodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France.
FAU - Le Deley, Marie-Cecile
AU  - Le Deley MC
AD  - Methodology and Biostatistics Unit, Centre Oscar Lambret, Lille, France.
FAU - Lartigau, Eric
AU  - Lartigau E
AD  - Academic Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.
AD  - CRIStAL UMR CNRS 9189, Lille University, Lille, France.
FAU - Marre, Delphine
AU  - Marre D
AD  - Department of Physics, Clinique Pasteur, Toulouse, France.
FAU - Pasquier, David
AU  - Pasquier D
AD  - Academic Department of Radiation Oncology, Centre Oscar Lambret, Lille, France.
AD  - CRIStAL UMR CNRS 9189, Lille University, Lille, France.
LA  - eng
PT  - Journal Article
DEP - 20210826
PL  - Switzerland
TA  - Front Oncol
JT  - Frontiers in oncology
JID - 101568867
PMC - PMC8427159
OTO - NOTNLM
OT  - *dosimetric analyses
OT  - *intensity-modulated radiotherapy
OT  - *intermediate risk group
OT  - *organs at risk
OT  - *prospective study
OT  - *prostate cancer
OT  - *quality of life
OT  - *spacer with biodegradable contrast-filled rectal balloon
COIS- The authors declare that this study received funding from BioProtect Ltd and 
      AQUILAB. The funder was not involved in the study design, collection, analysis, 
      interpretation of data, the writing of this article or the decision to submit it 
      for publication.
EDAT- 2021/09/14 06:00
MHDA- 2021/09/14 06:01
PMCR- 2021/01/01
CRDT- 2021/09/13 06:54
PHST- 2021/04/28 00:00 [received]
PHST- 2021/07/21 00:00 [accepted]
PHST- 2021/09/13 06:54 [entrez]
PHST- 2021/09/14 06:00 [pubmed]
PHST- 2021/09/14 06:01 [medline]
PHST- 2021/01/01 00:00 [pmc-release]
AID - 10.3389/fonc.2021.701998 [doi]
PST - epublish
SO  - Front Oncol. 2021 Aug 26;11:701998. doi: 10.3389/fonc.2021.701998. eCollection 
      2021.